Type 2 Diabetes Trial, Recruiting NCT07386340 Sponsor: Senseonics, Inc. Condition: Type 2 Diabetes
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Type 2 Diabetes Trial, Recruiting

NCT07386340
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 18 years of age or older
  • People who have had a confirmed diagnosis of diabetes mellitus for at least one year
  • People who have signed a consent form and are willing to follow the study requirements

Who may not be able to join:

  • People who have had a severe low blood sugar episode (one that caused loss of consciousness or a seizure) in the past 6 months
  • People who have had a diabetic ketoacidosis episode that required an emergency room visit or hospital stay in the past 6 months
  • People who have a condition called gastroparesis (where the stomach empties very slowly)
  • Women who are able to become pregnant and are currently pregnant, breastfeeding, planning to become pregnant, or not using birth control during the study
  • People who have a physical condition, upper limb deformity, or skin condition that would prevent a sensor from being placed, worn, or removed correctly
  • People with certain heart or blood pressure conditions, including chest pain at rest, a heart attack or stroke in the past 6 months, uncontrolled high blood pressure, heart failure, or a history of abnormal heart rhythms (confirm with trial site for full details, as some heart conditions may still be allowed with additional clearance)
  • People whose blood thickness (hematocrit) level is below 38% or above 60% at the screening visit
  • People with a history of hepatitis B, hepatitis C, or HIV
  • People currently being treated for a seizure disorder, unless a neurologist has provided written approval to participate
  • People with a history of adrenal insufficiency (a condition where the adrenal glands do not produce enough hormones)
  • People currently taking, or likely to need during the study, certain medications including immune-suppressing drugs, chemotherapy, blood thinners (not including aspirin), steroid creams over the sensor site, or long-term antibiotics for a chronic infection
  • People who have a condition that requires or is likely to require an MRI scan during the study
  • People with a known allergy to local or topical anaesthetics
  • People with a known allergy to glucocorticoids (a type of steroid medication)
  • People with any condition the study doctor believes would make participation unsafe or unsuitable, including certain mental health conditions or recent alcohol or drug misuse (confirm with trial site)
  • People who have taken part in another clinical trial within the 2 weeks before screening, or who plan to join another trial during the study
  • People who already have another active implanted medical device (confirm with trial site for specific details)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 667-218-3309

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Senseonics, Inc.
Registry
ClinicalTrials.gov
Start date
29 December 2025
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

System agreement (15/15%, 20/20%, 30/30%, and 40/40%) for paired sensor FGM and reference measurements post-insertion for reference glucose values from 40-400 mg/dL.; Number of device-related or sensor insertion/removal procedure-related serious adverse events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov